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IRCT20211014052767N1 IRCT 2021-11-09 Oroumia University of Medical Sciences Therapy of non alcoholic fatty liver disease Comparison of the therapeutic effects of pioglitazone and metformin in non-alcoholic fatty liver disease 2021-11-18 anticipated 110 Complete https://irct.ir/trial/59372 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Using a simple random number table, patients will be divided into two intervention groups (the first group receiving metformin 500 mg twice daily and the second group receiving pioglitazone 30 mg daily), Blinding description: After obtaining informed consent, patients will be randomly divided into two study groups, where each group will receive their intervention drug indefinitely from the researcher, and during the study, patients will not know the type of drug they received. 3 Non alcoholic fatty liver disease. Intervention 1: Intervention group 1: will recieve Tab. Metformin 500 mg twice daily (BID) oral for 3 months (Raha pharmaceutical Co.). Intervention 2: Intervention group 2: will recieve Tab. Pioglitazone 30 mg daily oral for 3 months ( Hakim Pharmaceutical Co. ). Yes - There is a plan to make this available What will be shared: Demographic information data and the main outcomes of the study will be shareable after identifying individuals. When: Access period begins 6 months after publication of study results To whom: The data will be available to researchers in research centers Conditions: Performing any analysis on the data that can be published is unrestricted for the applicants Where to obtain: Siavash Vakili, Siavash.v75@gmail.com How to obtain: The applicant can request access to the data via email to the respondent. The data will be provided to the applicant within 3 months after checking the conditions Comments:
public Siavash Vakili
Oroumia University of Medical Sciences headquarters , Emergency alley , Resalat Blvd. , resalat ave.
Oroumia Iran (Islamic Republic of) 5714783734 +98 87 3623 6558 siavash.v75@gmail.com Oroumia University of Medical Sciences scientific Siavash Vakili
Oroumia University of Medical Sciences headquarter , Emergency alley , Resalat Blvd.
Oroumia Iran (Islamic Republic of) 5714783734 +98 87 3623 6558 siavash.v75@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Grade 2 and 3 non-alcoholic fatty liver disease based on the latest ultrasound findings 18 years no limit Both History of long term alcohol consumption History chronic and acute viral and autoimmune hepatitis, type 1 diabetes, cholestatic diseases including cholecystitis, kidney, thyroid disease, various malignancies, severe infectious diseases, cardiovascular disease and immune deficiency History of pioglitazone, metformin, NSAIDs, fibrates, statins and warfarin Pregnancy and lactation History of corticosteroids and steroid compounds in the last three months Controlled diet or strenuous exercise K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group 1: will recieve Tab. Metformin 500 mg twice daily (BID) oral for 3 months (Raha pharmaceutical Co.) Intervention group 2: will recieve Tab. Pioglitazone 30 mg daily oral for 3 months ( Hakim Pharmaceutical Co. ) Liver sonographic findings. Timepoint: At the beginning of the study and 3 months after the start of the drug intervention. Method of measurement: Based on the classification of fatty liver. Liver enzymes. Timepoint: At the beginning of the study and 3 months after the start of the drug intervention. Method of measurement: Laboratory data. Oroumia University of Medical Sciences Approved 2021-10-01 Ethics committee of Oroumia University of Medical Sciences Oroumia University of Medical Sciences headquarter , Resalat ave. , Emergency alley Oroumia West Azarbaijan Iran (Islamic Republic of)